Actrapid® 10mL vial
Protaphane® 10mL vial
Human insulin (rys)
Consumer Medicine Information
What is in this leaflet
blood sugar (glucose) level. Extra
insulin is therefore needed.
What human insulin is used for
.................................................... 1 There are two types of diabetes
mellitus:
Before you use human insulin . 1 Type 1 diabetes – also called
juvenile onset diabetes
How to use human insulin........ 2 While you are using human
insulin ........................................ 5 Side effects ................................. 6 After using human insulin ....... 6 Product Description ................. 6 Further information ................. 7 This leaflet answers some
common questions about human
insulin 10mL vials. It does not
contain
all
the
available
information. It does not take the
place of talking to your doctor,
diabetes education nurse or
pharmacist.
All medicines have risks and
benefits.
Your doctor has
weighed the risks of you using
human insulin against the benefits
they expect it will have for you.
If you have any concerns about
using this medicine, ask your
doctor,
diabetes
education
nurse or pharmacist.
Keep this leaflet with the
medicine. You may need to read
it again.
What human insulin is
used for
Human insulin is used to treat
diabetes mellitus.
Diabetes
mellitus is a condition where your
pancreas does not produce
enough insulin to control your
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Type 2 diabetes – also called
maturity onset diabetes
Patients with type 1 diabetes
always require insulin to control
their blood sugar levels.
Some patients with type 2
diabetes may also require insulin
after initial treatment with diet,
exercise and tablets.
Human insulin lowers your blood
sugar level after injection. Each of
the following human insulins is
available in a 10mL vial:
Actrapid® is Neutral Insulin
Injection, a fast-acting insulin.
This means that it will start to
lower your blood sugar level
about half an hour after you inject
it, and the effect will last for
approximately 8 hours. Actrapid®
is often used in combination with
longer-acting insulin products.
Protaphane® is Isophane Insulin
Injection, an intermediate-acting
insulin. This means that it will
start to lower your blood sugar
level about one and a half hours
after you inject it, and the effect
will last for approximately 24
hours. Protaphane® is often used
in combination with fast- or
rapid-acting insulin products.
As with all insulins, the duration
of action will vary according to
the type of insulin, the dose,
injection site, blood flow,
temperature and level of physical
activity.
Actrapid® is also used by doctors
to treat some people with diabetes
in emergency situations.
Human insulin is not addictive.
Human insulin is available only
with a doctor’s prescription.
Ask your doctor if you have any
questions about why human
insulin has been prescribed for
you.
Before you use
human insulin
When you must not use it
Do not use human insulin if:
1. you have an allergy to:
 any
medicine
containing
insulin
 any of the ingredients listed in
the “Ingredients” section of
this leaflet.
Some of the symptoms of an
allergic reaction may include:
 redness, swelling, rash
and itching at the
injection site;
 rash, itching or hives on
the skin;
 shortness of breath;
 wheezing or difficulty
breathing;
 swelling of the face, lips,
tongue or other parts of
the body.
2. you are experiencing a low
blood sugar level (a “hypo”)
when the dose is due.
If you have a lot of hypos
discuss appropriate treatment
with your doctor.
If you are not sure whether you
should start using this medicine,
talk to your doctor.
Do not inject Protaphane® into
a vein.
Do not use Protaphane® to treat
a condition known as diabetic
ketoacidotic coma.
Page 1 of 7
Do not use this medicine after
the expiry date printed on the
label and carton, or if the
packaging is torn or shows signs
of tampering.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
Before you start to use it
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have
had
any
medical
conditions,
especially
the
following:



kidney problems
liver problems
adrenal, pituitary or thyroid
gland problems
Tell your doctor if you are
pregnant or planning to become
pregnant.
Pregnancy may make managing
your diabetes more difficult.
Insulin needs usually decrease
during the first three months of
pregnancy and increase during the
last six months. Your doctor can
discuss with you the risks and
benefits involved.
Tell your doctor if you are
breast-feeding or planning to
breast-feed.
Your doctor or pharmacist can
discuss with you the risks and
benefits involved.
Inform your doctor as soon as
possible if you experience signs
of heart failure such as unusual
shortness of breath or rapid
increase in weight or localised
swelling (oedema).
Some patients with long-standing
type 2 diabetes mellitus and heart
disease or previous stroke who
are treated with thiazolidinediones
in combination with insulin may
develop heart failure.
If you have not told your doctor
about any of the above, tell
them before you use human
insulin.
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Taking other medicines

Tell your doctor if you are
taking any other medicines,
including any that you get
without a prescription from
your pharmacy, supermarket or
health food shop.
danazol used to treat
endometriosis, menorrhagia,
fibrocystic breast disease
and hereditary angioedema

oxymetholone – used to treat
certain blood disorders

octreotide - used to treat
gastrointestinal
endocrine
tumours and enlargement of
parts of the body (e.g. hands,
feet, head) caused by
abnormal growth hormone
levels

lanreotide – used to treat
enlargement of parts of the
body (e.g. hands, feet, head)
caused
by
abnormal
hormone levels

diazoxide - used to treat high
blood pressure

nicotinic acid - used to treat
high cholesterol levels in the
blood

asparaginase - used to treat
leukaemia and lymph gland
tumours

quinine – used to treat
malaria and relieve muscle
cramps

quinidine – used to treat
heart problems

growth hormone – used to
treat growth disorders
Some medicines and human
insulin may interfere with each
other. These include:






oral hypoglycaemic agents used to treat type 2 diabetes
monoamine
oxidase
inhibitors (MAOI) - used to
treat depression
non-selective beta-blockers used to treat certain heart
conditions and high blood
pressure
alpha-blockers - used to treat
high blood pressure and to
relieve difficulty in passing
urine caused by an enlarged
prostate
angiotensin
converting
enzyme (ACE) inhibitors used to treat certain heart
conditions,
high
blood
pressure
or
elevated
protein/albumin in the urine
salicylates e.g. aspirin - used
to relieve pain and lower
fever

anabolic steroids – used to
promote growth

glucocorticoids
(except
when applied locally) – used
to
treat
inflammatory
conditions

oral contraceptives (“the
pill”) - used for birth control
Tell your doctor about any
other medicines that you are
taking.
This is very important. Your
doctor will advise you if it is
alright to keep taking them or if
you should stop taking them.

thiazides,
frusemide
or
ethacrynic acid - used to
treat high blood pressure or
fluid retention (oedema)
Your doctor and pharmacist have
more information on medicines to
be careful with or avoid while
using this medicine.

thyroid hormones - used to
treat malfunction of the
thyroid gland

sympathomimetics - used to
treat asthma

sulphonamides – used to
treat bacterial infections
Or other
including:
specific
medicines
How to use human
insulin
Your doctor, diabetes education
nurse or pharmacist will have
given you advice on how to use
your medicine. Carefully follow
all the directions.
Page 2 of 7
They may differ from the
information contained in this
leaflet.

Any change in dose or type of
insulin
should
be
made
cautiously and only under
medical supervision.
Checking your human insulin
vial:
If you change the type of insulin
that you use, you may have to use
more or less than before. This
may happen with the first dose or
over a period of time.
On first use of a new vial check
that the protective colourcoded, tamper-proof plastic cap
is in place, and is not loose or
missing.
If you do not understand the
instructions, ask your doctor,
diabetes education nurse or
pharmacist for help.
If it isn’t in perfect condition
when you receive the vial, return
it to your pharmacist.
How much to use
Check your vial before each
preparation and injection to
make sure you are using the
correct type and strength of
insulin. Disinfect the rubber
membrane with a medicinal
swab.
Your doctor or diabetes education
nurse will tell you how much of
this medicine you need to use.
It is very important that you
manage your diabetes carefully.
Too much or too little insulin can
cause serious effects.
When to use it
Your doctor or diabetes education
nurse will tell you when and how
often to inject the insulin.
How to use it




You need to use U100 insulin
syringes.
You should inject human
insulin under the skin
(subcutaneous injection) as
shown to you by your doctor
or diabetes education nurse.
In an emergency, the insulin
contained within Actrapid®
10mL vial is suitable for
intramuscular administration
under medical guidance. In
an emergency, the insulin
contained within Actrapid®
10mL vial is also suitable for
intravenous administration,
but only if administered by a
physician. Discard the vial
after emergency use.
In an emergency, the insulin
contained within Protaphane®
10mL vial is suitable for
intramuscular administration
under medical guidance.
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Discard the vial after
emergency use.
Do not use these human
insulin 10mL vials with
insulin pumps.
Remove the protective cap.
Do not use your Actrapid®
10mL vial unless the insulin
appears clear and colourless.
Do not use it if the insulin
appears thickened or has bits in
it.
Do not use your Protaphane®
10mL vial if the insulin is no
longer
a
cloudy,
white
suspension after rolling, or if it
has bits in it.
Using one insulin type:
1. Wash your hands.
2. If you are using Protaphane® just before use, roll the vial
between your hands until the
liquid is white and uniformly
cloudy. Do not shake the vial.
3. Draw air into a U100 syringe
equal to the dose of insulin to
be injected.
7. Then pull the needle out of the
vial. Expel any air from the
syringe and check that the
dose is correct.
8. If you need to put the syringe
down, make sure the needle
does not touch anything.
Mixing two insulin types:
Only mix insulins if your doctor
or diabetes education nurse has
instructed you to.
Follow your doctor’s or diabetes
education nurse’s instructions on
whether to mix your insulins
ahead of time or just before you
inject. It is important to be
consistent in your method.
1. Wash your hands.
2. Roll the vial of Protaphane®
(cloudy insulin) between your
hands until the liquid is white
and uniformly cloudy. Do not
shake the vial.
3. Draw air into the syringe
equal to the dose of
Protaphane® you are using.
Insert the needle into the
Protaphane® vial and inject the
air. Withdraw the needle
without drawing up any
insulin.
4. Draw air into the syringe
equal to the dose of fast- or
rapid-acting (clear) insulin
you are using. Insert the
needle into the vial of clear
insulin and inject the air. Do
not withdraw the needle.
5. Turn the vial and syringe
upside down.
6. Make sure the tip of the
needle is in the clear insulin
and withdraw the correct dose
of clear insulin into the
syringe.
4. Put the needle through the
rubber top of the vial and
inject the air into the vial.
7. Pull the needle out of the vial
of clear insulin. Expel any air
from the syringe and check
that the dose is correct.
5. Turn the vial and syringe
upside down.
8. Insert the needle into the vial
of Protaphane®.
6. Make sure that the tip of the
needle is in the insulin and
withdraw the correct insulin
dose into the syringe.
9. Turn the vial and syringe
upside down.
10. Make sure the tip of the
needle is in the insulin and
Page 3 of 7
withdraw the correct dose of
Protaphane® into the syringe.
11. Remove the needle from the
vial. Expel any air from the
syringe and check that the
dose is correct.
12. If you need to put the syringe
down, make sure the needle
does not touch anything.
If you use too much
(overdose) Hypoglycaemia
 to turn you on your side and
get
medical
help
immediately.
Your blood sugar level may
become too low (you may
experience hypoglycaemia or a
“hypo”) if you:
 not to give you anything to

accidentally use too much of
this medicine
Always mix the two insulins in
the same order as described
above.

have too much or unexpected
exercise

delay eating meals or snacks
Injecting a dose

eat too little food
Choose a site for injection.

are ill
Inject the medicine into the
abdomen, thighs, upper arms or
buttocks.
The first symptoms of mild to
moderate hypos can come on
suddenly. They may include:
Your insulin will work more
quickly if you inject into the
abdomen.

cold sweat, cool pale skin

fatigue, drowsiness, unusual
tiredness and weakness

nervousness, anxious feeling,
tremor, rapid heart beat
Change the injection site so that
the same position is not used
more often than once a month.
This will reduce the chance of
local skin reactions developing.
Pinch the skin between two
fingers, push the needle into the
raised skin, and inject the full
dose of insulin under the skin.
Slowly count to 6 before pulling
the needle out.

confusion,
concentrating

excessive hunger

vision changes

headache, nausea
difficulty
Always carry some sugary food
or fruit juice with you.
Do not rub the area.
If you experience any of these
symptoms of a hypo, immediately
eat some sugary food or have a
sugary drink e.g. lollies, biscuits
or fruit juice.
After injecting
Do not inject any insulin if you
feel a hypo coming on.
Apply gentle pressure over the
injection site for several
seconds.
Dispose of your insulin syringes
safely into a yellow plastic
sharps container.
If you are using Actrapid®, it is
recommended that you eat a meal
or
a
snack
containing
carbohydrate within 30 minutes of
the injection.
Do not share
syringes.
needles
and
How long to use it
Do not stop using human
insulin unless your doctor tells
you to.
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Tell your relatives, friends,
close workmates or carers that
you have diabetes.
It is
important that they recognise
the signs and symptoms of a
hypo.
Make sure they know to give you
some sugary food or fruit juice for
mild to moderate symptoms of a
hypo.
If you lose consciousness, make
sure they know:
eat or drink.
This is because you could choke.
An injection of the hormone
glucagon may speed up recovery
from unconsciousness. This can
be given by a relative, friend,
workmate or carer who knows
how to give it.
If glucagon is used, eat some
sugary food or have a sugary
drink as soon as you are
conscious again.
If you do not feel better after this,
contact your doctor, diabetes
education nurse, or the closest
hospital.
If you do not respond to glucagon
treatment, you will require
medical attention.
See your doctor if you keep
having hypo reactions, or if you
have ever become unconscious
after using insulin.
Your insulin dose may need to be
changed.
If a severe hypo is not treated, it
can cause convulsions, brain
damage and even death.
If you miss a dose Hyperglycaemia
If you forget to inject your
insulin dose, test your blood
sugar level as soon as possible.
If you are not sure what to do,
talk to your doctor, diabetes
education nurse or pharmacist.
Do not use a double dose of
your insulin.
If it is almost time for your next
dose, skip the dose you missed
and use your next dose when you
are meant to.
Otherwise, use it as soon as you
remember and then go back to
using it as you would normally.
Your blood sugar levels may
become high (hyperglycaemia) if
you:
Page 4 of 7
 miss doses of insulin or use
less insulin than you need
 have uncontrolled diabetes
 exercise less than usual
 eat more carbohydrates than
usual
 are ill or stressed
High blood sugar levels over a
long period of time can lead to
too much acid in the blood
(diabetic ketoacidosis).
Contact
your
doctor
immediately if your blood sugar
level is high or you recognise
any of the following symptoms.
Symptoms of mild to moderate
hyperglycaemia include:






drowsy feeling
flushed face
thirst, loss of appetite
fruity odour on the breath
blurred vision
passing larger amounts of
urine than usual
 getting up at night more often
than usual to pass urine
 high levels of glucose and
acetone in the urine
Symptoms
of
hyperglycaemia include:
severe





heavy breathing
fast pulse
nausea, vomiting
dehydration
loss of consciousness
Severe hyperglycaemia can lead
to unconsciousness and in
extreme cases death if untreated.
Discuss any worries you may
have about this with your
doctor,
diabetes
education
nurse or pharmacist.
While you are using
human insulin
Things you must do
Measure your blood sugar level
regularly.
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Make sure all friends, relatives,
workmates or carers know that
you have diabetes.
If your child has diabetes it is
important to tell their carers.
you
with
information.
Keep using your insulin even if
you feel well.
It helps to control your condition,
but does not cure it.
Do not stop using your medicine
unless your doctor tells you to.
Tell your doctor if you often
have hypos (low blood sugar
levels).
Your doctor may need to adjust
your insulin dose.
Always carry some sugary food
or fruit juice with you.
If you experience any of the
symptoms of a hypo, immediately
eat some sugary food or have a
sugary drink e.g. lollies, biscuits
or fruit juice.
some
helpful
Things you must not do
Do not use the medicine if you
think it has been frozen or
exposed to excessive heat.
It will not work as well.
Do not refill your
insulin 10mL vial.
human
Do not use this medicine to treat
any other complaints unless
your doctor tells you to.
Do not give your medicine to
anyone else, even if they have
the same condition as you.
Things to be careful of
Tell your doctor if you have
trouble
recognising
the
symptoms of hypos.
Under certain conditions, the
early warning signs of hypos can
be different or less obvious. Your
doctor may need to adjust your
insulin dose.
Be careful driving or operating
machinery until you know how
the insulin affects you.
Make sure that you tell every
doctor, dentist, pharmacist or
other health care professional
who is treating you that you
have diabetes and are using
insulin.
Tell your doctor if you are ill.
Illness, especially with nausea and
vomiting, may cause your insulin
needs to change. Even if you are
not eating, you still require
insulin. You and your doctor
should design an insulin plan for
those times when you are sick.
Tell your doctor, diabetes
education nurse or pharmacist
if you are travelling.
Ask them for a letter explaining
why you are taking injecting
devices with you. Each country
you visit will need to see this
letter, so you should take several
copies.
You may need to inject your
insulin and eat your meals at
different times because of time
differences in and between
countries.
You may not be able to get the
same type of insulin in the
country you are visiting.
Tell your doctor if you drink
alcohol.
Alcohol may mask the symptoms
of hypos.
Tell your doctor if you are
exercising more than usual.
Exercise may lower your need for
this medicine. Exercise may also
speed up the effect of a dose of it,
especially if the exercise involves
the area of the injection site (e.g.
the leg should not be used for
injection prior to jogging or
running).
Tell your doctor if your diet
changes.
Changes in diet may cause your
insulin needs to change.
Your doctor, diabetes education
nurse or pharmacist can provide
Page 5 of 7
Side effects
Tell your doctor, diabetes
education nurse or pharmacist
as soon as possible if you do not
feel well while you are using
human insulin.
This medicine helps most people
for whom it is prescribed, but it
may have unwanted side effects in
a few people. All medicines can
have side effects. Sometimes they
are serious, most of the time they
are not. You may need medical
treatment if you get some of the
side effects.
Do not be alarmed by the
following lists of side effects.
You may not experience any of
them.
Ask your doctor, diabetes
education nurse or pharmacist
to answer any questions you
may have.
The most common side effect
when using insulin is low blood
sugar levels (a hypo).
Tell your doctor if you notice
any of the following and they
worry you:
 hypos (mild to moderate)
 redness, swelling or itching at
the injection site. Usually
these symptoms disappear
within a few weeks during
continued use. If you have
serious
or
continuing
reactions, you may need to
stop using your current insulin
and use another insulin.
 a depression or thickening of
the skin around the injection
site (lipodystrophy)
 when you first start your
insulin treatment you may get
visual problems or swollen
hands and feet
This list includes the more
common side effects of your
medicine. They are usually mild
and short-lived.
If any of the following happen,
tell your doctor immediately or
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go to Accident and Emergency
at your nearest hospital:
More severe symptoms of low
blood sugar levels, including:
 disorientation
 seizures, fits or convulsions
 loss of consciousness
If a severe hypo is not treated, it
can cause brain damage and
death.
Tell your doctor immediately or
go to Accident and Emergency
at your nearest hospital if you
notice any of the following:
 skin rashes over a large part
of the body
 shortness of breath, wheezing
 swelling of the face, lips or
tongue
 fast pulse
 sweating
This list includes very serious side
effects. You may need urgent
medical
attention
or
hospitalisation. These side effects
are very rare.
Tell your doctor if you notice
anything that is making you feel
unwell.
Other side effects not listed above
may also occur in some people.
Ask your doctor, diabetes
education nurse or pharmacist
to answer any questions you
have.
After using human
insulin
Storage
Store human insulin 10mL vials
that are not being used between
2C and 8C in the refrigerator
(away from the cooling element).
Protect the insulin in the 10mL
vials from light by keeping
them in their cartons when not
in use.
Vials that you are using, or that
you are carrying as a spare,
should not be kept in a
refrigerator. You can use them up
to 4 weeks after taking them out
of the refrigerator if kept below
25ºC. Discard the vial after 4
weeks even if there is still some
insulin left in it.
Vials must not be frozen, or
exposed to excessive heat or light.
Never use insulin after the
expiry date printed on the label
and carton after ‘Expiry.’
The expiry date refers to the last
day of that month.
Never use Actrapid® 10mL vials
if the solution is not clear and
colourless.
Never use Protaphane® 10mL
vials if the suspension does not
become white and uniformly
cloudy after resuspending.
Keep out of the reach of
children.
Disposal
Dispose of your insulin syringes
safely into a yellow plastic
sharps container.
If your doctor tells you to stop
using this medicine or the
expiry date has passed, ask your
pharmacist what to do with any
medicine that is left over.
Product Description
What it looks like
Actrapid® is a clear, colourless
solution
for
subcutaneous
injection. Actrapid® 10mL vial is
a glass vial.
Protaphane® is a white, cloudy
suspension for subcutaneous
injection. Protaphane® 10mL vial
is a glass vial.
Ingredients
Human
insulin
(rys)
is
characterised by being identical to
natural human insulin.
The
abbreviation “rys” indicates the
method of genetic engineering
used to manufacture the insulin.
Actrapid® is a neutral solution of
human insulin (rys) 100 IU/mL.
Page 6 of 7
Also contains: glycerol, metacresol, zinc chloride, water for
injections. Hydrochloric acid and
sodium hydroxide are used to
adjust the pH.
is
a
neutral
Protaphane®
suspension of isophane human
insulin (rys) 100 IU/mL. Also
contains: glycerol, meta-cresol,
phenol, dibasic sodium phosphate
dihydrate,
zinc
chloride,
protamine sulfate, water for
injections. Hydrochloric acid and
sodium hydroxide are used to
adjust the pH.
Sponsor
Human insulin 10mL vials are
supplied in Australia by:
Novo Nordisk Pharmaceuticals
Pty Ltd
Level 3
21 Solent Circuit
Baulkham Hills NSW 2153
This leaflet was prepared on 30
August 2012.
Australian Registration Numbers:
Actrapid® 10mL vial:
AUST R 169625
Protaphane® 10mL vial:
AUST R 169637
Actrapid®,
Protaphane®
and
®
are
registered
NovoCare
trademarks of Novo Nordisk A/S.
© 2012
Further information
For further information call the
NovoCare® Customer Care Centre
on 1800 668 626.
www.novonordisk.com.au
You can also get more
information about diabetes and
insulin from Diabetes Australia:

freecall helpline 1300 136
588
 www.diabetesaustralia.com.au
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